Actively Recruiting
A Real World Study on Local Infiltration of Bupivacaine Liposome Injection for Acute Postoperative Pain After Pediatric Orthopedic Surgery
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-10-02
232
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of bupivacaine liposome injection for local pain relief in children aged 6 to 17 undergoing orthopedic surgery. This Phase 4 study focuses on real-world use of this treatment to manage acute postoperative pain. The study is sponsored by Jiangsu HengRui Medicine Co., Ltd. and aims to understand how well this analgesic works and its safety profile in pediatric patients. Participants will receive bupivacaine liposome injection at a dose of 4 mg/kg, up to a maximum of 266 mg, applied locally during surgery. The study observes patients from the time of administration through the postoperative period, monitoring pain control and the need for additional opioid pain medications. This is an interventional study without masking or placebo control. During the study, researchers will closely track adverse events related to the heart and nervous system for up to 14 days after treatment. They will measure opioid use, time to first opioid rescue medication, pain scores at rest and during movement for different age groups, and length of hospital stay up to two weeks. Participants will undergo regular assessments to evaluate pain relief and safety throughout the 72-hour postoperative period and beyond.
CONDITIONS
Brief Title
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length of 3 cm or more.
- Children aged 6 to 17 years, male or female.
- ASA Physical Status Classification I-III.
You will not qualify if you...
- Received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.
- History of immunodeficiency diseases or use of immunosuppressants in the past 30 days.
- Presence of mental health conditions or difficulty communicating.
- History of chronic pain or visceral pain.
- Abnormal liver or kidney function.
- Clinically significant abnormal heart rate or rhythm.
- Participation in any other interventional clinical trial.
- Other conditions deemed inappropriate for participation by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 72 hours after administration
Participants receive a Bupivacaine Liposome Injection for local analgesia after pediatric orthopedic surgery.
1 administration visit and multiple assessments up to 72 hours
Duration - Up to 2 weeks
Participants are monitored for adverse events and recovery during their hospital stay.
Approximately 1 to 2 visits during hospital stay
Trial Site Locations
Total: 1 location
1
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
T
Thea Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Frequently Asked Questions
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